Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients

Golnaz Sadjadieh; Thomas Engstrøm; Dan Eik Høfsten; Steffen Helqvist; Lars Køber; Frants Pedersen; Peter Nørkjær Laursen; Hedvig Bille Andersson; Lars Nepper-Christensen; Peter Clemmensen; Rikke Sørensen; Erik Jørgensen; Kari Saunamäki; Hans Henrik Tilsted; Henning Kelbæk; Lene Holmvang

doi:10.1016/j.amjcard.2018.07.008

Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients

Golnaz Sadjadieh^*
, Thomas Engstrøm
, Dan Eik Høfsten
, Steffen Helqvist
, Lars Køber
, Frants Pedersen
, Peter Nørkjær Laursen
, Hedvig Bille Andersson
, Lars Nepper-Christensen
, Peter Clemmensen
, Rikke Sørensen
, Erik Jørgensen
, Kari Saunamäki
, Hans Henrik Tilsted
, Henning Kelbæk
, Lene Holmvang

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

Abstract

Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.

Original language	English
Pages (from-to)	1287-1296
Number of pages	10
Journal	American Journal of Cardiology
Volume	122
Issue number	8
DOIs	https://doi.org/10.1016/j.amjcard.2018.07.008
Publication status	Published - 15 Oct 2018

Funding

This research is supported by the Danish Agency for Science, Technology and Innovation, the Danish Council for Strategic Research (EDITORS, grant 09-066994 ), the Danish Heart foundation , the Research foundation of Rigshospitalet , the Research Foundation of the Department of Cardiology in Rigshospitalet , the A.P. Møller Foundation , and the Aase and Einar Danielsen Foundation . Dr. Køber reports grants from The Danish Research Foundation. Dr. Engstrøm reports fees from St. Jude Medical, Bayer, Boston Scientific and AstraZeneca. Dr. Clemmensen reports grants from Abbott, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli-Lilly, Evolva, Fibrex, Janssen, Merck, Myogen, Medtronic, Mitsubishi Pharma, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Regado, Sanofi, Searle, Servier, ViFor Pharma, and Zoll Medical Corporation. The remaining authors have nothing to declare.

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10.1016/j.amjcard.2018.07.008

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Sadjadieh, G., Engstrøm, T., Høfsten, D. E., Helqvist, S., Køber, L., Pedersen, F., Laursen, P. N., Andersson, H. B., Nepper-Christensen, L., Clemmensen, P., Sørensen, R., Jørgensen, E., Saunamäki, K., Tilsted, H. H., Kelbæk, H., & Holmvang, L. (2018). Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients. American Journal of Cardiology, 122(8), 1287-1296. https://doi.org/10.1016/j.amjcard.2018.07.008

@article{44fb206d5ed542e38253625023277038,

title = "Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients",

abstract = "Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4\% day 0 to 30 and 2.1\% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2\% vs 2.9\%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95\% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0\% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95\% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.",

author = "Golnaz Sadjadieh and Thomas Engstr{\o}m and H{\o}fsten, \{Dan Eik\} and Steffen Helqvist and Lars K{\o}ber and Frants Pedersen and Laursen, \{Peter N{\o}rkj{\ae}r\} and Andersson, \{Hedvig Bille\} and Lars Nepper-Christensen and Peter Clemmensen and Rikke S{\o}rensen and Erik J{\o}rgensen and Kari Saunam{\"a}ki and Tilsted, \{Hans Henrik\} and Henning Kelb{\ae}k and Lene Holmvang",

year = "2018",

month = oct,

day = "15",

doi = "10.1016/j.amjcard.2018.07.008",

language = "English",

volume = "122",

pages = "1287--1296",

journal = "American Journal of Cardiology",

issn = "0002-9149",

publisher = "Elsevier",

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Sadjadieh, G, Engstrøm, T, Høfsten, DE, Helqvist, S, Køber, L, Pedersen, F, Laursen, PN, Andersson, HB, Nepper-Christensen, L, Clemmensen, P, Sørensen, R, Jørgensen, E, Saunamäki, K, Tilsted, HH, Kelbæk, H & Holmvang, L 2018, 'Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients', American Journal of Cardiology, vol. 122, no. 8, pp. 1287-1296. https://doi.org/10.1016/j.amjcard.2018.07.008

Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients. / Sadjadieh, Golnaz; Engstrøm, Thomas; Høfsten, Dan Eik et al.
In: American Journal of Cardiology, Vol. 122, No. 8, 15.10.2018, p. 1287-1296.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients

AU - Sadjadieh, Golnaz

AU - Engstrøm, Thomas

AU - Høfsten, Dan Eik

AU - Helqvist, Steffen

AU - Køber, Lars

AU - Pedersen, Frants

AU - Laursen, Peter Nørkjær

AU - Andersson, Hedvig Bille

AU - Nepper-Christensen, Lars

AU - Clemmensen, Peter

AU - Sørensen, Rikke

AU - Jørgensen, Erik

AU - Saunamäki, Kari

AU - Tilsted, Hans Henrik

AU - Kelbæk, Henning

AU - Holmvang, Lene

PY - 2018/10/15

Y1 - 2018/10/15

N2 - Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.

AB - Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.

UR - https://www.scopus.com/pages/publications/85051410447

U2 - 10.1016/j.amjcard.2018.07.008

DO - 10.1016/j.amjcard.2018.07.008

M3 - Article

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AN - SCOPUS:85051410447

SN - 0002-9149

VL - 122

SP - 1287

EP - 1296

JO - American Journal of Cardiology

JF - American Journal of Cardiology

IS - 8

ER -

Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical Trial Compared With Unselected Patients

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